The present invention relates to a device for establishment of a permanent pathway between the abdominal cavity or an organ situated in the abdominal cavity and the exterior of the body to permit for example chronic peritoneal dialysis or other forms of treatment of the abdominal cavity or organs situated therein.
Every year, some 55-60 patients per million inhabitants in Sweden encounter chronic kidney failure. As a rule, the failure is a relatively slowly progressing condition requiring active uremic treatment, ie dialysis treatment and/or kidney transplantation. During the 1960s and 1970s haemodialysis has been the predominant form of treatment, while peritoneal dialysis has been a second-choice alternative on account of the practical problems encountered.
In 1978, however, the foundation was laid, both practically and theoretically, for so-called continuous peritoneal dialysis (CAPD) and since then technical developments have made CAPD increasing popular. A survey of the number of dialysis patients in Sweden conducted on 18 Sept. 1984 revealed that a total of 1 071 patients were being treated with some kind of dialysis. Of these, 221 were being treated with chronic peritoneal dialysis. The corresponding figure for Europe as of 31 Dec., 1983, shows that 60 691 patients were receiving haemodialysis and haemofiltration treatment, while 5 385 patients were being treated with peritoneal dialysis.
When the CAPD treatment was first introduced, it was found that infections in the abdominal cavity, so-called peritonitis, were far more common with CAPD treatment than with the otherwise normally used intermittent peritoneal dialysis treatment. The CAPD treatment has several clinical and laboratory advantages in comparison with the haemodialysis treatment. Provided that further development takes place on the technical side, increasing interest in CAPD as a form of treatment may be anticipated. Hitherto, this technical development has largely been concentrated on the connection between dialysis solution, usually supplied in 2-liter disposable plastic bags, and the catheter in the patient's abdominal cavity. Various disinfection routines have reduced the risk for contamination due to handling of the system by the patient. Since 1978, this technical development has resulted in a reduced frequency of peritonitis to the current level of around 1 peritonitis per 8 patient observation months. The bacteria staphylococcus epidermidis normally present on the skin is the commonest cause of peritonitis. A major share of the cases of peritonitis however can not be attributed to technical handling of the equipment but has some other origin.
Another clinically highly important complication is the so-called tunnel infection around the inserted peritoneal dialysis catheter. Due to the fact that the technique and materials currently used often cause a rejection phenomena with a tunnel or recess formation adjacent to the catheter, a serious infection often arises. These tunnel infections, often caused by staphylococcus aureus in some instances, cause peritonitis.